Drug intelligence / Profile preview

ongiciclib

Development stage
Phase 3
Lead developer
Fochon Biosciences
Modality
Small Molecules
Administration
Oral
01

Overview

Ongiciclib is an orally bioavailable, potent, and highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Developed by Fochon Pharmaceuticals, a subsidiary of Fosun Pharma, the drug is primarily indicated for the treatment of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Its mechanism involves binding to the ATP-binding site of CDK4 and CDK6, thereby preventing the formation of the CDK4/6-cyclin D complex. This inhibition blocks the phosphorylation of the retinoblastoma (Rb) protein, leading to cell cycle arrest in the G1 phase and suppressing tumor cell proliferation. Ongiciclib is currently undergoing Phase 3 clinical evaluation in combination with endocrine therapies, showing potential as a next-generation CDK4/6 inhibitor with improved selectivity and safety profiles.

Other names
fovinaciclibFCN-437cFCN437cFCN 437cFCN-437FCN437FCN 437
02

Targets

CDK4 (Cyclin-dependent kinase 4)CDK6 (Cyclin-dependent kinase 6)

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